U.S. patent application number 17/743558 was filed with the patent office on 2022-08-25 for vented connector for medical fluid vessels and tapered plug.
The applicant listed for this patent is Avent, Inc.. Invention is credited to John Burke, Mark M. Costello, Benjamin Martin Davis, David A. Doornbos, Aaron N. Ingram.
Application Number | 20220265987 17/743558 |
Document ID | / |
Family ID | |
Filed Date | 2022-08-25 |
United States Patent
Application |
20220265987 |
Kind Code |
A1 |
Ingram; Aaron N. ; et
al. |
August 25, 2022 |
Vented Connector for Medical Fluid Vessels and Tapered Plug
Abstract
A connector for medical fluid vessels includes a fluid-seal
fitting such as a male plug defining a lumen and mating with a
cooperating connector, a mechanical fastener such as a screw thread
for mating with the cooperating connector, and an outer housing
positioned around the plug to form an annular space. A cap can be
provided with a fluid-seal fitting such as a male plug for mating
with the lumen of the connector. In example embodiments, the male
plug is tapered and can comprise one or more projections for
sealingly engaging with the lumen of the connector. According to
some example embodiments, the cap can be tethered to the
connector.
Inventors: |
Ingram; Aaron N.; (Canton,
GA) ; Davis; Benjamin Martin; (Woodstock, GA)
; Costello; Mark M.; (Co. Mayo, IE) ; Doornbos;
David A.; (Woodstock, GA) ; Burke; John;
(Galway City, IE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Avent, Inc. |
Alpharetta |
GA |
US |
|
|
Appl. No.: |
17/743558 |
Filed: |
May 13, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16001282 |
Jun 6, 2018 |
11357964 |
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17743558 |
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14844956 |
Sep 3, 2015 |
10668263 |
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16001282 |
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62515880 |
Jun 6, 2017 |
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62047389 |
Sep 8, 2014 |
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62192614 |
Jul 15, 2015 |
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International
Class: |
A61M 39/20 20060101
A61M039/20; A61M 39/10 20060101 A61M039/10; A61J 15/00 20060101
A61J015/00 |
Claims
1-24. (canceled)
25. A connector for connection to a fluid vessel and a cooperating
connector, the connector comprising: a first end configured to
attach to the vessel, a second end, and a lumen extending through
the connector from the first end to the second end; a fluid-seal
fitting that at least partially defines the lumen and is configured
to sealingly mate with the cooperating connector to provide
conveyance of the fluid; an outer housing positioned around the
fluid-seal fitting to form an annular space therebetween with an
access opening at the second end of the connector, wherein the
outer housing comprises a sidewall having at least one vent opening
extending therethrough to provide fluid communication between the
annular space and external to the annular space; and a cap
repositionable between a plugged position capping the second end of
the connector and an unplugged position not capping the second end
of the connector, the cap including one or more vent openings to
provide fluid communication between the annular space and external
to the annular space when the cap is in the plugged position
capping the access opening of the annular space, wherein the one or
more cap vent openings allow for drainage and air-drying of any
residual amount of fluid in the annular space, wherein the cap
further comprises a plug for providing sealed engagement with the
lumen, the plug comprising an elongate body extending from a first
end to a second end, an outer peripheral surface, and at least one
projection extending around the outer peripheral surface of the
plug, the at least one projection providing for an interference fit
with an internal surface of the lumen to seal the lumen from
outside contamination.
26. The connector of claim 25, wherein the plug tapers from the
first end to the second end.
27. The connector of claim 25, wherein the plug comprises a length
of about 5 millimeters.
28. The connector of claim 25, wherein the at least one projection
comprises a rib-like ring projecting around the entire periphery of
the outer peripheral surface of the plug body, and wherein an outer
surface of the rib-like ring is configured for providing an
interference fit with the internal surface of the lumen of the male
connector.
29. The connector of claim 25, wherein the plug comprises two or
more projections.
30. The connector of claim 29, wherein each projection has a
thickness that is unequal to the thickness of any other
projection.
31. The connector of claim 29, wherein each of the projections are
equally spaced apart from each other along the elongate body of the
plug.
32. The connector of claim 30, wherein each projection has a
diameter along the elongate body that is unequal to the diameter of
each other projection.
33. The connector of claim 25, wherein the at least one projection
of the plug comprises four spaced-apart projections, each of the
projections extending around the entire periphery of the plug.
34. The connector of claim 25, wherein the at least one projection
comprises an outer diameter of between about 3.0-3.5 millimeters
and wherein the internal diameter of the lumen is about 2.90
millimeters.
35. The connector of claim 34, wherein at least between about
0.040-0.180 millimeters of interference is provided between the at
least one projection and the interior surface of the lumen.
36. The connector of claim 35, wherein the interference fit between
the at least one projection and the lumen is such that a removal
force of between about 2.5-15 N is required to remove the
fully-inserted plug from the lumen.
37. The connector of claim 25, wherein at least a portion of the
lumen comprises a recessed portion or annular undercut defined
therein configured for receiving the at least one projection of the
plug of the cap.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the priority benefit of U.S.
Provisional Patent Application Ser. No. 62/515,880 filed Jun. 6,
2017, and is a continuation-in-part of U.S. Non-Provisional patent
application Ser. No. 14/844,956 filed Sep. 3, 2015, which claims
the priority benefit of U.S. Provisional Patent Application Ser.
No. 62/047,389 filed Sep. 8, 2014 and U.S. Provisional Patent
Application Ser. No. 62/192,614 filed Jul. 15, 2015, the entireties
of which are hereby incorporated herein by reference for all
purposes.
TECHNICAL FIELD
[0002] The present invention relates generally to medical devices,
and more particularly to connectors for vessels for fluids in the
medical field, and to tethered capping plugs for sealing engaging
with connectors for vessels for fluids.
BACKGROUND
[0003] Healthcare patients are commonly given fluids such as
medication and nutrients by being connected to fluid-delivery
systems via fluid vessels. Common fluid vessels for delivering such
fluids include small-bore tubes and catheters. A problem arises
when these fluid tubes are misconnected. That is, when a tube from
one fluid delivery system is connected to a tube intended for
connection to another fluid delivery system that serves a
completely different function, for example, when a feeding
administration set is inadvertently connected to a tracheostomy
tube. Such tubing misconnections are also referred to as LUER
misconnections, small-bore misconnections, and/or wrong-route
errors. Tubing misconnections have resulted in patient injuries
and/or deaths, and are widely recognized as underreported.
[0004] An underlying cause of these misconnections has been
attributed to the universal design of LUER connectors, which are
one of the most commonly used types of small-bore connectors in
healthcare. These connectors are used to couple the tubing of one
medical device to another. However, the simple design and ease of
use of LUER connectors allows the tube of the device of one
delivery system to be connected to a tube of an unrelated system
that has a different intended use (e.g., vascular, enteral,
respiratory, epidural, or intrathecal), resulting in healthcare
providers inadvertently connecting wrong systems together and
thereby causing liquids (e.g., medications or enteral feedings) or
gases (e.g., oxygen) to be delivered through the wrong route.
[0005] Efforts are underway to develop standards, such as the ISO
80369 standards, for tubing connections. These standards hold the
promise of significantly addressing the tubing-misconnection
problem. For example, these standards provide for a new connector
for enteral feeding tubes that prevents misconnection to
non-enteral connectors. This new enteral-only tube connector is
also referred to as the ENFIT connector.
[0006] Yet there remain other opportunities for improving these and
other connectors. For example, the new ENFIT connector for enteral
feeding tubes includes an outer housing that could retain feeding
liquids and thereby allow for bacteria colonization. This can
result in unsanitary conditions that can inadvertently contaminate
feeding fluids later delivered to the patient through the degraded
ENFIT connector.
[0007] Accordingly, it can be seen that needs exist for improved
connectors for fluid tubes to reduce the risk of bacteria
colonization. It is to the provision of solutions to this and other
needs that the present invention is primarily directed.
SUMMARY
[0008] In example embodiments, the present invention relates to
individual connectors as well as connector-sets (of individual
connectors) for coupling together two medical-fluid vessels. The
connectors and connector-sets advantageously provide for drainage
and air-drying of any residual fluid that might otherwise be
retained and result in bacteria colonization, as well as for
breaking a vacuum to prevent fluid backflow and thus ensure more
accurate dosing.
[0009] In one aspect, the present invention relates to a connector
that includes a fluid-seal fitting such as a male plug for mating
with a cooperating connector, a mechanical fastener such as a screw
thread for mating with the cooperating connector, and an outer
housing positioned around the plug to form an annular space. The
connector outer housing includes one or more vent openings for
drainage and air-drying of any residual fluid in the annular space
when the cap is plugged on. For example, the connector vent
openings can be in an endwall of the outer housing, a peripheral
sidewall of the outer housing, or both.
[0010] In another aspect, the invention relates to a sanitary cap
that includes a fluid-seal fitting such as a male plug for mating
with a lumen of the connector plug. The cap includes one or more
vent openings for drainage and air-drying of any residual fluid in
the annular space when the cap is plugged on. For example, the cap
vent openings can be in an endwall body of the cap, a peripheral
sidewall of the cap, or both. In some embodiments in which the cap
vent openings are in the cap sidewall, they are formed by notches
or recesses between segments of the cap sidewall, and in these or
other similar embodiments mechanical stop surfaces are provided on
the cap and the connector to limit to travel of the cap sidewall
relative to the outer-housing sidewall to ensure that the cap vents
remain open for ventilation.
[0011] In another aspect, the invention relates to a fluid-seal
fitting such as a male plug for mating with a cooperating
connector. The male plug can be tapered and comprise one or more
projections formed on an outer periphery portion thereof for
providing an interference with a lumen of the connector. In one
example embodiment, the plug comprises about four spaced-apart
ribs. In example embodiments, each rib generally extends around the
entire periphery of the plug.
[0012] In another aspect, the invention relates to a cap for
sealing with a lumen of a male connector. In example embodiments,
the cap includes a body having an upper surface and a lower
surface. The upper surface includes a handle extending therefrom
and the lower surface includes a plug extending therefrom. The plug
has a first end engaged with the lower surface and a second end
axially extending therefrom. In example embodiments, the plug
includes at least one projection extending therefrom for sealing
engagement with the lumen of the male connector.
[0013] In example embodiments, the plug comprises an elongate body
and an outer peripheral surface, and wherein the plug tapers from
the first end to the second end. In example embodiments, the plug
comprises a length of about 5 millimeters.
[0014] In example embodiments, the at least one projection has a
rib-like ring projecting around the entire periphery of the outer
peripheral surface of the plug body, and wherein an outer surface
of the rib-like ring is configured for providing an interference
fit with an internal surface of the lumen of the male connector.
According to some example embodiments, the plug includes two or
more projections. According to one example embodiment, the plug
includes four spaced-apart projections, each of the projections
extending around the entire periphery of the plug. In example
embodiments, the at least one projection has an outer diameter of
between about 3.0-3.5 millimeters and wherein the internal diameter
of the lumen is about 2.90 millimeters. In example embodiments, at
least between about 0.040-0.180 millimeters of interference is
provided between the at least one projection and the interior
surface of the lumen. In example embodiments, the projections and
interference with the lumen is such that a removal force of between
about 2.5-15 N is required to remove the fully-inserted plug from
the lumen. In example embodiments, a first projection is spaced
about 1.389 millimeters from the second end, a second projection is
spaced about 2.392 millimeters from the second end, a third
projection is spaced about 3.392 millimeters from the second end,
and a fourth projection is spaced about 4.392 millimeters from the
second end. In example embodiments, the first projection has an
outer diameter of about 3.024 millimeters, the second projection
has an outer diameter of about 3.034 millimeters, the third
projection has an outer diameter of about 3.051 millimeters, and
the fourth projection has an outer diameter of about 3.2
millimeters. In example embodiments, the cap further includes a
tether for tethering the cap to the male connector.
[0015] In yet another aspect, the invention relates to a connector
for connection to a fluid vessel and a cooperating connector, the
connector including a first end from which the vessel extends, a
second end, and a lumen extending therethrough from the first end
to the second end; a fluid-seal fitting that at least partially
defines the lumen and sealingly mates with the cooperating
connector to provide conveyance of the fluid; an outer housing
positioned around the fluid-seal fitting to form an annular space
therebetween with an access opening at the second end of the
connector; and a cap repositionable between a plugged position
capping the connector second end and an unplugged position not
capping the connector second end, the cap including one or more
vent openings extending between the annular space and external to
the annular space when the cap is in the plugged position capping
the access opening of the annular space, wherein the one or more
cap vent openings allow for drainage and air-drying of any residual
amount of the fluid in the annular space, and wherein the cap
further comprises a plug for providing sealed engagement with the
lumen, the tapered plug comprising at least one projection
extending around the outer periphery of the plug, the at least one
projection providing for an interference fit with an interior
surface of the lumen.
[0016] In example embodiments, the plug includes an elongate body
and an outer peripheral surface, and wherein the plug tapers from
the first end to the second end. In example embodiments, the plug
has a length of about 5 millimeters. In example embodiments, the at
least one projection has a rib-like ring projecting around the
entire periphery of the outer peripheral surface of the plug body,
and wherein an outer surface of the rib-like ring is configured for
providing an interference fit with an internal surface of the lumen
of the male connector. In example embodiments, the plug includes
two or more projections. In example embodiments, the plug includes
four spaced-apart projections, each of the projections extending
around the entire periphery of the plug.
[0017] In example embodiments, the at least one projection has an
outer diameter of between about 3.0-3.5 millimeters and wherein the
internal diameter of the lumen is about 2.90 millimeters. In
example embodiments, at least between about 0.040-0.180 millimeters
of interference is provided between the at least one projection and
the interior surface of the lumen. In example embodiments, the
projections and interference with the lumen is such that a removal
force of between about 2.5-15 N is required to remove the
fully-inserted plug from the lumen. In example embodiments, a first
projection is spaced about 1.389 millimeters from the second end, a
second projection is spaced about 2.392 millimeters from the second
end, a third projection is spaced about 3.392 millimeters from the
second end, and a fourth projection is spaced about 4.392
millimeters from the second end. In example embodiments, the first
projection includes an outer diameter of about 3.024 millimeters,
the second projection includes an outer diameter of about 3.034
millimeters, the third projection includes an outer diameter of
about 3.051 millimeters, and the fourth projection includes an
outer diameter of about 3.2 millimeters. In example embodiments, at
least a portion of the lumen includes a recessed portion or annular
undercut defined therein configured for receiving the at least one
projection of the plug of the cap.
[0018] These and other aspects, features, and advantages of the
invention will be understood with reference to the drawing figures
and detailed description herein, and will be realized by means of
the various elements and combinations particularly pointed out in
the appended claims. It is to be understood that both the foregoing
general summary description and the following brief description of
the drawings and detailed description of example embodiments are
exemplary and explanatory of preferred embodiments of the
invention, and are not restrictive of the invention, as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is a side view of a vented male connector according
to a first example embodiment of the present invention, shown with
a mating female connector and with its cap unplugged so that it's
ready for connection to the mating female connector.
[0020] FIG. 2 is a front perspective view of the male connector of
FIG. 1.
[0021] FIG. 3 is another front perspective view of the male
connector of FIG. 1.
[0022] FIG. 4 is a rear perspective view of the male connector of
FIG. 1.
[0023] FIG. 5 is another rear perspective view of the male
connector of FIG. 1.
[0024] FIG. 6 is a front view of the male connector of FIG. 1.
[0025] FIG. 7 is another side view of the male connector of FIG.
1.
[0026] FIG. 8 shows the male connector of FIG. 1 with its cap in a
plugged position.
[0027] FIG. 9 is a cross-sectional view of the male connector of
FIG. 8 showing a ventilation passageway for airflow through the
connector with its cap in a plugged position.
[0028] FIG. 10 is a perspective view of a vented connector
according to a second example embodiment, shown with its cap
unplugged so that it's ready for connection to a mating female
connector.
[0029] FIG. 11 is a perspective view of a vented connector
according to a third example embodiment, shown without its cap.
[0030] FIG. 12 shows a perspective view of a tethered plug for
sealingly engaging with the lumen of the connector according to
another example embodiment of the present invention, the plug
having one or more projections provided thereon.
[0031] FIG. 13 is a cross-sectional view of the tethered plug of
FIG. 12.
[0032] FIG. 14 detailed view of a portion of the tethered plug of
FIG. 13.
[0033] FIG. 15 is a cross-sectional view of the tethered plug of
FIG. 13 connected and plugging the lumen of a male connector.
[0034] FIG. 16 shows a cross-sectional view of a tethered plug
according to another example embodiment of the present
invention.
[0035] FIGS. 17-18 show an assembly view of a tethered plug and
male connector according to another example embodiment of the
present invention, the plug having one or more projections thereon
and the male connector defining a lumen extending therethrough
wherein one or more undercuts or receivers are provided for
receiving one or more projections of the tethered plug.
DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
[0036] The present invention may be understood more readily by
reference to the following detailed description taken in connection
with the accompanying drawing figures, which form a part of this
disclosure. It is to be understood that this invention is not
limited to the specific devices, methods, conditions, or parameters
described and/or shown herein, and that the terminology used herein
is for the purpose of describing particular embodiments by way of
example only and is not intended to be limiting of the claimed
invention. Any and all patents and other publications identified in
this specification are incorporated by reference as though fully
set forth herein.
[0037] Also, as used in the specification including the appended
claims, the singular forms "a," "an," and "the" include the plural,
and reference to a particular numerical value includes at least
that particular value, unless the context clearly dictates
otherwise. Ranges may be expressed herein as from "about" one
particular value and/or to "about" another particular value. When
such a range is expressed, another embodiment includes from the one
particular value and/or to the other particular value. Similarly,
when values are expressed as approximations, by use of the
antecedent "about," it will be understood that the particular value
forms another embodiment.
[0038] With reference now to the drawing figures, wherein like
reference numbers represent corresponding parts throughout the
several views, FIGS. 1-9 show a vented connector 30 according to a
first example embodiment of the invention. The connector 30
attaches to a medical fluid vessel 10 and mates with a cooperating
connector 20 attached to an inline medical fluid vessel 12, with
the connectors collectively forming a connector-set or coupling
that detachably couples the vessels together for fluid flow
therethrough. The connectors 20 and 30 can be made of conventional
materials (e.g., as silicone or polyurethane) by conventional
fabrication techniques and equipment (e.g., molding).
[0039] In the depicted embodiment, the vented connector 30 is
attached to a vessel 10 that is a tube, though the term "vessel" is
intended to be broadly construed to include any carrier or
container for a fluid as well as any fluid-delivery device, and as
such in other embodiments the vessel is a catheter, hose, bottle,
bag, syringe, pump, or the like. As such, the connectors 20 and 30
can be used to couple together two vessels (with one vessel in/at
the patient and the other vessel connected to an upstream medical
fluid-delivery device such as a syringe) or to couple one vessel to
a medical device (with one vessel in/at the patient and the other
vessel being or a part of an upstream medical fluid-delivery device
such as a syringe). In the depicted embodiment, the vented
connector 30 is used for a vessel 10 for enteral feeding, with the
term "vessel" in the "enteral feeding" context intended to be
broadly construed to include not just feeding bags but also breast
pumps, food bottles, other food-storage containers, extension sets,
and the like. In the depicted embodiment, the vented connector 30
is an ENFIT connector for enteral feeding tubes, though in other
embodiments the innovative features are included in connectors for
fluid vessels for non-enteral and/or non-small-bore (medical or
other) applications. And in the depicted embodiment, the vented
connector 30 is a male connector and the cooperating connector 20
is a mating female connector, though in other embodiments this is
reversed to provide a vented and/or capped female connector with an
outer housing defining an annular space. In addition, the vented
connector 30 is described herein for use with fluids, which as used
herein means liquids and gases.
[0040] The connector 30 includes a vessel-attaching portion 32
defining a rear end 34, a coupling-attaching portion 36 defining a
front end 38, and a lumen 40 extending longitudinally therethrough
from end to end. The vessel-attaching portion 32 attaches to (e.g.,
receives and secures) the vessel 10 and secures it in place with a
good seal by conventional structures such as crimps or adhesives so
that the vessel extends longitudinally from the rear end 34. The
coupling-attaching portion 36 and the cooperating connector 20
detachably couple together mechanically by mating attachment
fittings such as the depicted screw threads 42 and 22 (of the
connector 30 and the cooperating connector 20, respectively) or
other conventional mating mechanical fasteners as are known to
persons of ordinary skill in the art such as bayonet fitting,
snap-fit couplings, and the like. And the coupling-attaching
portion 36 and the cooperating connector 20 sealingly mate together
for fluid conveyance by mating male and female fittings such as the
depicted male plug 44 and female receptacle 24 (of the connector 30
and the cooperating connector 20, respectively) or other
conventional fluid-sealing structures as are known to persons of
ordinary skill in the art such other friction fittings. In the
depicted embodiment, the male plug 44 includes a peripheral wall
that defines the lumen 40 extending axially all the way through it
to convey the fluid through the connector 30. In some embodiments,
the mating male and female seal fittings are designed to provide
sufficient mechanical/frictional retention forces that the
connectors 30 and 20 are securely coupled together and the
connectors 30 and 20 thus do not include any separate screw
threading or other mechanical fasteners.
[0041] In addition, the connector 30 includes an outer housing 46
surrounding its plug 44, for example including a peripheral
sidewall 48 and an endwall 50. The outer-housing sidewall 48 is
arranged coaxially with and surrounding the plug 44 thereby forming
an annular space 52 therebetween with an access opening at the
front end 38 of the connector 30 (opposite the endwall). In this
way, when the two connectors are coupled together with the male
plug 44 of the connector 30 inserted into the female receptacle 24
of the cooperating connector 20, the peripheral sidewall or barrel
26 (defining the receptacle 24) of the cooperating connector 20 is
coaxially received in the annular space 52 (between the
outer-housing peripheral sidewall 48 and the plug 44) of the
connector 30. And the connectors 30 and 20 can be coupled together
by the screw threads 42 being inner threads on the outer-housing
sidewall 48 and the mating threads 22 being outer threads on the
receptacle sidewall 26, by mating threads between the plug and the
receptacle sidewall, or by other threading arrangements. The
outer-housing sidewall 48 of the connector 30 and the receptacle
sidewall 26 of the cooperating connector 20 are typically generally
cylindrical in shape and solid in structure (i.e., not fluid
permeable).
[0042] The outer-housing endwall 50 extends at least partially
between the outer-housing sidewall 48 and the plug 44, with at
least one (e.g., two, as depicted) connecting portion 54 extending
inwardly from the outer-housing sidewall to fix the outer-housing
sidewall relative to the plug and thereby form the annular space
52. Typically each connecting portion 54 extends all the way
between (e.g., radially, as depicted) and fixes together the
outer-housing sidewall 48 and the plug 44. To provide for fluid
drainage and airflow ventilation, the outer-housing endwall 50 of
the connector 30 includes at least one (e.g., two, as depicted)
vent openings 56 providing fluid communication between the annular
space 52 and external to the annular space. The connector vent
openings 56 can be in the form of two curved slots extending
between two connecting portions 54 in the form of radial spokes, as
depicted. Alternatively, the connector vent openings can be in the
form of ports (e.g., holes in a circular, polygonal,
frusto-conical, or other regular or irregular shape) extending
axially through the endwall and/or radially through the outer
sidewall, mesh openings in an endwall that is a mesh (e.g., a
screen, grate, or lattice), or other types and arrangements of
openings that provide for fluid drainage and airflow ventilation
for the annular space. In addition, the outer-housing endwall 50
has an inner surface (partially defining the annular space 52) that
can be sloped (ramped or taper, all or only part of it) toward the
connector vent openings 56 to help direct fluid toward them.
[0043] In this way, any residual fluid from the vessels 10 and 12
that might otherwise be retained in the annular space 52 resulting
in bacteria colonization will instead tend to drain out through the
connector vent openings 56 and be dried by airflow in and/or out of
the vent openings. Furthermore, the connector vent openings 56 in
the outer-housing endwall 50 provide better access to the annular
space 52 for inspection and cleaning. Moreover, when the connector
30 is disconnected from the cooperating connector 20, a vacuum can
form in the lumen 40 and induce a backflow of the fluid into the
connector 30 and/or the cooperating connector 20, resulting in
dosing inaccuracies, and the connector vent openings 56 can
function to assist in breaking the vacuum to prevent fluid backflow
and thus provide for more accurate dosing.
[0044] In addition, the connector 30 optionally includes a sanitary
cap 70 for the lumen 40 at its front end 38 (opposite the
attachment of the vessel 10). The cap 70 can be attached to the
connector 30 by a tether 72 such as an integral length of material
(as shown) or a cord, string, band, chain, or the like. In
addition, the cap 70 can include a handle 73 for gripping to move
the cap between its unplugged (see FIGS. 1-7) and plugged positions
(see FIGS. 8-9). In the plugged position the cap 70 seals off the
lumen 40 and the vessel 10 from outside contamination, which can be
advantageous for example in enteral feeding applications in which
the vessel 10 is inserted into the patient and left there for
future feedings.
[0045] The cap 70 includes a body or endwall 74 with a seal fitting
(e.g., a plug) 76 and a peripheral sidewall 78 axially extending
from it. The cap body/endwall 74 is typically a solid member such
as a panel for sealing the annular space when capped. And the cap
sidewall 78 can be a solid peripheral member such as a collar or
flange, or two or more peripherally arranged prongs such as fingers
or tabs, for reception and retention in the annular space when
capped. In the plugged position, the cap plug 76 is received in the
connector-plug lumen 40 at its front end 38 with a snug fit for
sealing to prevent the escape of fluids from the vessel 10. And the
cap sidewall 78 is received in the annular space 52 through its
access opening so that it engages the connector 30 with a snug fit
for mechanical/frictional retention to removably secure the cap 70
in place in the plugged position. In other embodiments, the cap
seal fitting is a sleeve, recess, or other structural element that
mates with the connector seal fitting to seal the lumen closed. And
in yet other embodiments, the cap 70 and the connector 30
additionally or alternatively include mating screw threads or other
fasteners for removably securing the parts together.
[0046] To provide for fluid drainage and airflow ventilation of the
annular space 52 when the cap 70 is the plugged position, the cap
includes at least one (e.g., three, as depicted) vent openings 80
providing fluid communication between the annular space and
external to the annular space. The cap vent openings 80 can be in
the form of one or more notches defined by gaps between one or more
segments of the cap sidewall 78, for example the three curved
notches between the three segments of the cap sidewall formed by
the undulating edge of the cap sidewall, as depicted.
Alternatively, the cap vent openings can be in the form of ports
(e.g., holes in a circular, polygonal, conical, or other regular or
irregular shape) extending axially through the cap body/endwall
and/or radially through the cap sidewall, mesh openings in a
portion of the cap body that is a mesh (e.g., a screen, grate, or
lattice), or other types and arrangements of openings that provide
for fluid drainage and airflow ventilation for the annular space
with the cap in the plugged position.
[0047] In this way, any residual fluid from the vessels 10 and 12
that might otherwise be retained in the annular space 52 (upon
disconnection of the connectors 30 and 20) resulting in bacteria
colonization will instead tend to drain out through the cap vent
openings 80 and be dried by airflow in and/or out of the vent
openings. Furthermore, the cap vent openings 80 can facilitate
better inspection and cleaning of the annular space 52. Moreover,
the connector vent openings 56 and the cap vent openings 80, in
combination with the annular space 52, form a continuous passageway
(see FIG. 9) for airflow to enter the annular space at one end and
exit the other end for enhanced drying and to prevent an airlock
that might restrict airflow in and out of the annular space. As
such, as used herein reference to connector outer-housing vent
openings being "at the outer-housing endwall" includes the vent
opening being formed in or by the outer-housing endwall 50 as well
as being formed in or by the outer-housing sidewall 48 but
immediately adjacent the outer-housing endwall to provide the
continuous airflow passageway along substantially the entire length
of the annular space 52.
[0048] In addition, to make sure that the cap vent openings 80 are
at least partially exposed and uncovered (sufficiently for
functioning for their intended purpose as described herein) when
the cap 70 is in the plugged position on the connector 30, engaging
stop surfaces 58 and 82 can be provided on the connector and the
cap, respectively, to define (and thus limit) the how far the cap
fits onto the connector. In the depicted embodiment, for example,
the connector stop surface 58 is formed by a rim of the connector
plug 44 defining the lumen 40, and the cap stop surface 82 is
formed by a base of the cap plug 76. As can be seen for example in
FIGS. 8-9, in the plugged position the cap vent openings 80 are
partially covered but still partially exposed to permit fluid flow
therethrough. Alternatively, the connector and cap stop surfaces
can be formed by at least one inward-extending member (e.g., a
collar, flange, rib, tab, or the like) of the outer-housing
sidewall and by the rear (insertion) ends of the cap sidewall
segments, respectively, so the inward-extending members limit how
far into the annular space the cap sidewall segments can be
inserted. Further alternatively, the connector stop surface can be
in the form of an endwall, collar, flange, rib, tab, or the like on
or adjacent the connector plug and/or lumen (e.g., within the
lumen), and/or the cap stop surface can be in the form of a skirt,
collar, flange, rib, tab, wing, or the like on or adjacent the cap
plug.
[0049] It should be noted that the depicted embodiment includes the
connector vent openings 56 and the cap vent openings 80 in
combination, while other embodiments include only one of these two
features. Furthermore, it should be noted that some embodiments
include connector vent openings in the outer-housing sidewall as an
addition or alternate to the depicted connector vent openings 56 in
the outer-housing endwall 48, while other embodiments include cap
vent openings in the cap endwall as an addition or alternate to the
depicted cap vent openings 80 in the cap sidewall 78. As such, any
of the vent openings disclosed herein can be implemented
individually or in any combination with any other vent opening(s)
disclosed herein or not disclosed herein.
[0050] FIG. 10 shows a vented connector 130 according to a second
example embodiment of the present invention. The vented connector
130 is substantially similar to that of the first example
embodiment described above, with exceptions as noted herein. In
this embodiment, for example, the connector 130 includes one or
more vent openings 186 formed in the outer-housing sidewall 148, in
addition to the one or more vent openings 156 formed in the
outer-housing endwall (not shown) described above. The connector
vent openings 186 in the outer-housing sidewall 148 provide for
drainage and drying, vacuum breaking, and enhanced inspection and
cleaning similarly to the venting in the first example
embodiment.
[0051] In the depicted embodiment, the connector vent openings 186
are generally circular in shape, though in other embodiments the
vent openings can have an oval, polygonal, conical, or other
regular or irregular shape. The depicted connector vent openings
186 are positioned sufficiently away from the front/cooperating
connector end of the connector 130 that they are not blocked by the
cap sidewall segments when the cap 170 is plugged onto the
connector (with the cooperating connector detached). In other
embodiments, the vent openings are provided with deflectors (e.g.,
V-shaped members extending inward from the inner surface of the
outer-housing sidewall and positioned between the vent openings and
the front end) that are engaged by and induce rotation of the cap
sidewall segments when the cap is plugged onto the connector so
that the vent openings align with the cap sidewall vent openings.
And in still other embodiments, an array or series of the sidewall
vent openings are provided.
[0052] In addition, the cap 170 can have one or more vent openings
184 axially formed in the cap body or endwall 174. The cap vent
openings 184 are positioned radially outward from the cap plug 176
so that when the cap 170 is plugged onto the connector 130 they
provide ventilation to the annular space 152 but they do not
provide ventilation to the lumen 140. The cap vent openings 184 can
be in the form of curved slots (as depicted) or they can have a
circular, polygonal, conical, or other regular or irregular shape.
In other embodiments, the connector 120 includes only the cap vent
openings 184 or only the connector vent openings 186.
[0053] FIG. 11 shows a vented connector 230 according to a third
example embodiment of the present invention. The vented connector
230 is substantially similar to those of the first and second
example embodiments described above, with exceptions as noted
herein. In this embodiment, for example, the connector 230 includes
the one or more vent openings 286 formed in the outer-housing
sidewall 248, but not any vent openings formed in the outer-housing
endwall. The connector vent openings 286 in the outer-housing
sidewall 148 provide for drainage and drying, vacuum breaking, and
enhanced inspection and cleaning similarly to the venting in the
first and second example embodiments. It should be noted that the
connector 230 is depicted without a cap, though in some embodiments
a cap is provided, and the cap can include cap vent openings as
described herein as an addition or alternate to the connector vent
openings 286.
[0054] As described above, the cap comprises a plug that is
configured for sealing off the lumen of the connector from outside
contamination. In example embodiments, the plug is generally
substantially cylindrical with a generally uniform outer periphery
having a generally consistent outer diameter. According to example
embodiments, the plug is configured such that interference with the
lumen occurs when the plug is fully inserted therein or for example
within about 1 millimeter from being fully inserted. According to
example embodiments, the lumen comprises a diameter of about 2.90
millimeters.
[0055] FIGS. 12-15 show a cap 300 according to another example
embodiment of the present invention. In example embodiments, the
cap 300 is substantially similar to the caps as described above,
for example, comprising a body 310, a sidewall 320, and one or more
vent openings 350 defined by gaps in the sidewall 320. In example
embodiments, the cap body 310 further comprises an upper surface
312 from which a handle 330 extends (e.g., for gripping) and a
lower surface 314 from which a plug 360 extends. In example
embodiments, the plug 360 comprises one or more projections, ribs
or other surface features 380 provided thereon, for example, to
provide for an interference fit with the lumen of the male
connector (see FIG. 15).
[0056] As depicted in FIG. 13, the plug 360 axially extends along
an elongate axis X between a first end 366 (generally adjacent and
abutting the lower surface 314) and a second end 367 to define a
length L1 therebetween (see FIG. 14). In example embodiments, the
plug 360 comprises a cylindrical body 362 and an outer peripheral
surface 364. According to example embodiments, the body 362 is not
entirely cylindrical, for example, wherein an angle a is defined
between the elongate axis X and the outer periphery 364 of the plug
360. According to example embodiments, the plug 360 comprises at
least some taper thereto, for example, wherein the angle a is
generally between about 0.5-20 degrees, for example between about
7-15 degrees according to one example embodiment. In one example
embodiment, a first radiused transition is provided where the lower
surface 314 and the first end 366 abut or engage each other, and a
second radiused transition 372 is provided for extending between
the outer surface 364 and the second end 367. According to example
embodiments, the plug 360 is generally integrally formed with the
lower surface 314 of the cap 300. However, according to other
example embodiments, the plug 360 can be movably mounted thereto,
or can be a separate piece that is generally movably mounted or
removably mountable to the lower surface 314.
[0057] In example embodiments, one or more ribs, sealing features
or projections 380 are provided on the outer surface 364 of the
plug body 362, for example, which generally extends outwardly
therefrom and around the entire periphery thereof to define a
generally raised abutment or seal ring for engagement with the
lumen 410 of the male connector 400 (see FIG. 15). As such, the
outermost periphery or outer surface of the one or more projections
380 provides for an interference fit with the lumen 410 of the male
connector 400. In example embodiments, the plug 360 comprises an
array of about four spaced-apart projections 380 positioned along
the length L1, for example, wherein each projection 380 generally
extends around the entirety of the outer surface 364 of the plug
body 362.
[0058] As depicted in FIG. 14, the plug 360 comprises a first
projection 382 near the second end 367, a second projection 384
spaced apart from the first projection 382, a third projection 386
spaced apart from the second projection 384, and a fourth
projection 388 spaced apart from the third projection 386. In
example embodiments, each of the projections 382, 384, 386, 388
extend around the entirety of the plug body 360, and thus,
insertion within the lumen provides at least four separate sealing
surfaces wherein outer surfaces of the projections engage with the
interior surface of the lumen 410 (see FIG. 15). In example
embodiments, only one, two or three, or more than four projections
can be provided on the plug 360 so as to provide interference with
the lumen 410 of the male connector 400, for example, so as to
provide at least one seal between at least a portion of the
projection and the interior surface of the lumen 410.
[0059] According to the depicted example embodiment of FIG. 14, the
projections 382, 384, 386, 388 define a thickness RT and an outer
major radius RR. According to one example embodiment, the thickness
RT of the projection 382 is about 0.250 millimeters and the radius
RR is about 0.266 millimeters. According to example embodiments,
the thickness and radius of the projection 382 (or the other
projections 384, 386, 388) can be chosen as desired, for example,
at least between a thickness of between about 0.095-2.5 millimeters
and a radius of between about 0.075-1.5 millimeters. Optionally,
according to other example embodiments, the thickness and radius
can be chosen as desired. In alternate example embodiments, one or
more of the projections can be provided with various other
projections, ribs, tabs or other sealing features or elements in
various sizes and shapes, for example, so as to be configured to
allow for a desired about of interference or engagement with the
interior surface of the lumen 410. For example, according to
example embodiments, the projections are preferably configured so
as to provide a desirable pull or removal force, for example, such
that at least a minimum amount of force is required to disengage
the plug from the lumen. In example embodiments, the removal force
is generally configured to be between about 2.5-15 newtons (N). In
example embodiments, the plug 360 (and projections 382, 384, 386,
388) generally provide for an interference fit such that a removal
force of 6-8 newtons. In other example embodiments, the
interference fit is such that continuous insertion and removal of
the plug from the lumen at least provides for a removal force of
about 2.5 N.
[0060] As described above, the plug 360 extends a length L1 between
the lower surface 314 and the second end 367. In example
embodiments, the length L1 is generally between about 2.25-8.50
millimeters, more preferably between about 4-7 millimeters, for
example about 5.03 millimeters according to one example embodiment.
The plug comprises a first outer diameter D1 that is generally near
the first end 366 and a second outer diameter D2 that is generally
near the first projection 382. According to one example embodiment,
the first outer diameter D1 is about 2.871 millimeters and the
second outer diameter D2 is about 2.478 millimeters, for example,
such that at least some taper is provided along the length of the
plug body 362 (e.g., defined by angle .alpha.). According to one
example embodiment, the angle .alpha. is about 3.5 degrees.
Accordingly, the entire angle between opposite sides of the outer
surface 364 is about 7 degrees according to one example embodiment.
According to another example embodiment, the angle .alpha. is
between about 4-8 degrees. According to another example embodiment,
the angle .alpha. can be chosen as desired, for example, between
about 0.25 degrees to about 16 degrees.
[0061] According to example embodiments, the first projection 382
is generally spaced a length L5 of about 1.389 millimeters from the
second end 367 and comprises an outer diameter D3 of about 3.024
millimeters. The second projection 384 is generally spaced a length
L4 of about 2.392 millimeters from the second end 367 and comprises
an outer diameter D4 of about 3.034 millimeters. The third
projection 386 is generally spaced a length L3 of about 3.392
millimeters from the second end 367 and comprises an outer diameter
D5 of about 3.051 millimeters. The fourth projection 388 is
generally spaced a length L2 of about 4.392 millimeters from the
second end 367 and comprises an outer diameter D6 of about 3.20
millimeters.
[0062] According to example embodiments, the diameters, lengths,
radii or other dimensions of the plug can preferably be varied as
desired, for example, so as to provide a desired interference fit
with the lumen of the male connector while providing a desired
removal force. According to example embodiments, the dimensions as
described above can preferably comprise tolerances up to about 0.10
millimeters. Thus, according to some example embodiments, the
diameters, lengths or other dimensions of the plug as described
above can preferably vary at least by .+-.0.10 millimeters.
According to other example embodiments, the dimensions can be
chosen as desired.
[0063] According to example embodiments (as described above), the
one or more projections can preferably comprise a desired amount of
interference I with the lumen 410. For example, as depicted in FIG.
15, the first projection 382 defines the interference I provided
between the lumen 410. According to one example embodiment, with
the lumen comprising an inner diameter D7 of about 2.90 millimeters
and with the first projection 382 comprising a diameter D3 of about
3.024 millimeters, the interference I provided between the first
projection 382 and the lumen 410 is about 0.062 millimeters.
According to other example embodiments, the interference I can be
between about 0.0125-0.350 millimeters, for example between about
0.040-0.180 millimeters according to one example embodiment.
[0064] According to the depicted example embodiment, the second
projection 384 comprises an interference I of about 0.067
millimeters (D4=3.034 mm and D7=2.90 mm), the third projection 386
comprises an interference I of about 0.076 millimeters (D5=3.051 mm
and D7=2.90 mm), and the fourth projection 388 comprises an
interference I of about 0.150 millimeters (D6=3.20 mm and D7=2.90
mm). Thus, according to one example embodiment, the fourth
projection 388 comprises greater interference with the lumen 410
than the third projection 386, the third projection comprises
greater interference with the lumen 410 than the second projection
384, and the second projection comprises greater interference with
the lumen 410 than the first projection 382. Optionally, according
to other example embodiments, the projections can be dimensioned to
provide a desired amount of interference with the lumen.
[0065] According to another example embodiment, the projections
382, 384, 386, 388 can be thickened such that the width thereof is
increased while generally keeping the outer diameters the same. For
example, the cap 500 as depicted in FIG. 16 comprises a plug 560
comprising a plurality of projections as is described above with
respect to the cap 300. In example embodiments, the projections
582, 584, 586, 588 comprise substantially similar diameters in
comparison to the projections 382, 384, 386, 388 of the plug
360.
[0066] However, the first projection 582 comprises a thickness
RT.sub.2 of about 0.650 millimeters, for example, about 0.400
millimeters greater than the thickness RT of the projection 382. In
example embodiments and in a similar manner as described above, the
second projection 584 comprises a thickness that is about 0.300
millimeters greater than the thickness of the projection 384, the
third projection 586 comprises a thickness that is about 0.200
millimeters greater than the thickness of the projection 386, and
the fourth projection 588 comprises a thickness that is about 0.100
millimeters greater than the thickness of the projection 388.
[0067] According to yet another example embodiment of the present
invention, an annular recess or undercut can be provided with a
portion of the lumen or male connector, for example, so as to
provide for engagement with one or more projections of the plug.
For example, as depicted in FIGS. 17-18, a cap 600 comprising a
plug 360 and one or more projections 380 is provided for sealing
engagement within a lumen 710 of a male connector 700. In example
embodiments, an internal surface 720 that is defined within the
lumen 710 comprises an annular undercut or recess 722 to provide
for engagement with the fourth projection 688. In example
embodiments, the undercut 722 is generally shaped similarly to the
profile of the projection 688, or for example, can be shaped as
desired to provide for at least some interference or engagement
when the plug is fully inserted within the lumen 710. According to
some example embodiments, the undercut 722 is at least slightly
larger than the profile of the projection 688 so as to provide
minimal interference when the plug 660 is seated within the lumen
710. However, upon removal or insertion, the projection 688 must
overcome the engagement or interference with the entrance of the
undercut 722 and along the internal surface 720. Accordingly, while
the undercut 722 can be configured to have substantially small
amounts of interference when the plug is fully inserted, insertion
and removal of the plug can be configured so as to provide a
desired removal force, for example, such that the plug is not
unintentionally removed causing unintentional exposure of the lumen
710 to the elements.
[0068] According to some example embodiments, the undercut can be
configured so as to provide less resistance when the plug is fully
inserted and rotating about the lumen 710. In some example
embodiments, the plug can comprise one or more projections intended
for an interference fit with the internal surface 720 of the lumen
710 and one or more projections intended for seating within one or
more undercuts provided within the lumen 710. In this manner, the
amount of interference can be chosen as desired so as to provide a
sufficient seal and a desired removal force. Furthermore, the
amount of interference can be chosen as desired to additional
provide for at least some rotational movement of the plug relative
to the lumen 710 while maintaining a desired removal force.
[0069] According to example embodiments, the cap (and plug thereof)
in addition to the connector and the hub of the lumen can be formed
from any desirable material including plastics, thermoplastics,
polymers, or other desirable materials. In example embodiments, the
cap (and plug thereof) is formed from a polyvinyl chloride
material. Optionally, other materials may be chosen as desired.
According to example embodiments, the male connector and lumen
thereof can be formed from a polymer material including
polypropylene (PP), acrylonitrile butadiene styrene (ABS), or
thermoplastic polyurethane (TPU). In additional example
embodiments, the cap, plug, projections, male connector or lumen
thereof can preferably be formed from any available desired
material (or a combination of two or more materials).
[0070] While the invention has been described with reference to
preferred and example embodiments, it will be understood by those
skilled in the art that a variety of modifications, additions and
deletions are within the scope of the invention, as defined by the
following claims.
* * * * *